In order to support the sharing of information on performed or planned studies and increase the efficiency of research, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and the European Medicines Agency (EMA) strongly encourage...
European Commission working on proposal to postpone MDR application date for one year
Medical devices make an essential contribution to healthcare in the EU for the benefit of European citizens. From sticking plasters to X-ray scanners, dentures to hip joints and in-vitro diagnostic devices that monitor diabetes or identify infections, medical devices...
COVID-19: what is the current situation of the International Authorities
A pneumonia of unknown cause detected in Wuhan, China was first reported to the World Health Organisation Country Office in China on 31 December 2019. After just three months WHO characterised COVID-19 as pandemic, currently affecting 157 countries and territories...
COVID-19: what is the current situation of the International Authorities
A pneumonia of unknown cause detected in Wuhan, China was first reported to the World Health Organisation Country Office in China on 31 December 2019. After just three months WHO characterised COVID-19 as pandemic, currently affecting 157 countries and territories...
TEDDY Network supports RARE DISEASE DAY
Even this year TEDDY Network supports the Rare Disease Day, the thirteenth edition of the international initiative promoting awareness-raising activities on Rare Disease and that took place on 29 February 2020. The first Rare Disease Day was celebrated in 2008 on 29...
EMA overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.
On January 2020, the European Medicines Agency (EMA) published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a...
SAVE THE DATE. EPTRI Open Meeting. 2-3 April 2020, Brussels
EPTRI (European Paediatric Translational Research Infrastructure) has announced the EPTRI Open Meeting that will be held on April 2-3 April 2020 at the President Brussels Hotel. EPTRI is an EU funded project coordinated by Consorzio per Valutazioni Biologiche e...
The activities of KIDS Bari keep on!
The activities of the Italian Young Persons Advisory Group (YPAG), KIDS Bari, keep on and this year will be focused on the development of a serious game on the theme of Paediatric Clinical Research and Clinical Trial Center, as a playful training tool for the young...
1500 downloads for the article “Clinical Trials in Paediatrics — Regulatory and Methodological Aspects”
In June 2014, IntechOpen Book, one of the world’s leading publisher of open access books, published the book entitled “Drug Discovery and Development - From Molecules to Medicine”, including a chapter written by Professor Adriana Ceci and experts from Gianni Benzi...
Zynteglo obtained marketing-authorisation for the treatment of beta thalassaemia in patients 12 years and older
In March 2019, the Committee for Medicinal Product for Human Use (CHMP) on the basis of the draft Committee for Advanced Therapies opinion, adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zynteglo, intended...